FDA proposes easing of medical device malfunctioning reporting

Today’s Federal Register includes a new FDA proposal that is meant to streamline voluntary malfunction summary reporting for medical device companies.

The proposal – which is now under a comment period until Feb. 26, 2018 – would allow a medtech company to provide certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis – instead of filing each individual MDR within 30 days.

Get the full story on our sister site Medical Design & Outsourcing. 

The post FDA proposes easing of medical device malfunctioning reporting appeared first on MassDevice.

from MassDevice http://ift.tt/2BTmPxK